Blood/Plasma Collection Device For Dna Testing
The Blood/Plasma Collection Device for DNA Testing is an in vitro diagnostics device intended to collect and transport blood or plasma specimens to the laboratory for clinical DNA testing, preserving nucleic acid integrity during transport. It is an FDA Class 2 device regulated under 21 CFR 862.1675, requiring 510(k) premarket notification, within the Clinical Chemistry (CH) medical specialty. The product code is PJE. This device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- PJE
- Device Class
- FDA class 2
- Regulation Number
- 862.1675
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 1
Device Characteristics
Definition
A blood collection device for DNA testing is an in vitro diagnostics device intended to collect and transport blood specimens to the laboratory for clinical DNA testing.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K231469 | PAXgene® Blood DNA Tube | Jun 21, 2023 | Substantially Equivalent | Preanalytix GmbH |
| K142821 | PAXgene Blood DNA Tube | Sep 09, 2015 | Substantially Equivalent | Preanalytix GmbH |
| K042927 | VACUETTE EDTA K3 EVACUATED BLOOD COLLECTION TUBES | Apr 15, 2005 | Substantially Equivalent | Greiner Bio-One Vacuette North America |
| K031359 | S-MONOVETTE EDTA K2-GEL | Sep 12, 2003 | Substantially Equivalent | Sarstedt, Inc. |
| K014104 | VACUETTE EDTA K2 TUBES | Feb 01, 2002 | Substantially Equivalent | Greiner Vacuette North America, Inc. |
| K012043 | VACUETTE EDTA K2 GEL TUBES | Sep 24, 2001 | Substantially Equivalent | Greiner Vacuette North America, Inc. |
| K010328 | MULTIPLE (IZON DNA BLOOD COLLECTION KIT) | Apr 09, 2001 | Substantially Equivalent | Izon Business Products, Inc. |
| K972075 | VACUTAINER BRAND PPT PLASMA PREPARATION TUBE | Feb 24, 1998 | Substantially Equivalent | Becton Dickinson Vacutainer Systems |
FEI Numbers
This FDA classification entry is associated with 18 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 18 registration numbers. Click on an entry to view related FDA registrations.